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AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer

RecruitingPhase 1

Sponsor: Chugai Pharmaceutical

Conditions: ALK Positive Non-small Cell Lung Cancer

Interventions: AQUA07, Lorlatinib

Countries: Japan

This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as single agent and in combination with lorlatinib in patients with ALK positive non-small cell lung cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form
* Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.)
* Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC
* Measurable disease per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Ability and willingness to take oral medication(s)
* Adequate organ function and bone marrow reserve

Exclusion Criteria:

* Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy
* Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy.
* Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease
* Significant cardiovascular disease
* Inadequately controlled hypertension

Locations (5)

Nagoya, Aichi-ken, Japan
Sakai, Osaka, Japan
Nagaizumi-cho, Shizuoka, Japan
Chuo-ku, Tokyo, Japan
Koto-Ku, Tokyo, Japan